On January 4, 2002, President Bush signed the Best Pharmaceuticals for Children Act (BPCA) to establish a process for studying on-patent and off-patent drugs for use in pediatric populations, and to improve pediatric therapeutics through collaboration on scientific investigation, clinical study design, weight of evidence, and ethical and labeling issues.The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads BPCA efforts on behalf of the National Institutes of Health (NIH), in part because of its record of success in the Pediatric Pharmacology Research Unit (PPRU) Network, a group of 13 sites and a data-coordinating center that have been conducting pediatric clinical trials since 1994. In addition, NICHD's strengths in conducting safe and effective clinical trials in populations thought to be fragile, such as children and pregnant women, also made the Institute the natural choice to help spearhead BPCA efforts of NIH.